Provides input in signal identification & evaluation
Provides Medical review of aggregate reports (PSUR, PADER, PBRER)
Prepares & reviews DSURs for timely submission to the regulatory authorities
Active participation & input in preparation of the REMS for USA products
Provides assistance in RMPs as needed
Provided medical review of ICSR including causality assessment
Reviews safety information on Labels via ELM
Provides safety input on protocols, CSRs, IB and informed consent
Provides medical input on AE, Conmed, Medical history listings including SAE reconciliation
Prepares Health hazard evaluation for post marketed products
Maintains the database (Ag balance)
Supervised, coordinated, and provided scientific guidance to Safety Surveillance and Risk Management teams for signal detection, signal management and safety governance including tracking of those activities, and teams training on signal detection and management
Prepared and presented individual cases to the external & internal expert panel for the REMS Safety board meeting
Global medical evaluation and documentation of SAEs and AESIs in clinical trials.
Provided review and safety updates on NDA, IB, CSR, protocols and IND reports
Authorized, prepared and review of aggregate reports including DSURS for timely submission to the regulatory authorities
Review aggregate reports including PADER, PBRER and PSUR of various products.
Provided review of company RSI including updates to the CCSI
Prepared and participated in CAPA meetings for Health Hazard Evaluation (HHE) of various pharmaceutical products and medical devices.
Prepared and assessed detail health hazard evaluation for post marketed products
Provided medical review and assessment of ICSR which includes causality assessment, narratives for CSR submission, and safety review for various trials in various phases
Provided expertise on safety data on Labels (OTC and Prescription) and safety information on labels using ELM
Other activities included providing key input for the review of new or ongoing safety documents that ensure compliance with domestic and international regulatory requirement that include, but may not be limited to, protocols, regulatory reports.
Other duties involved periodic SOP updates, periodic updates to HHE forms and other safety related forms
Mentored and trained drug safety teams on signal detection, health hazard evaluation, database training, clinical data review of patient profiles, adverse events, concomitant medication and medical history
Provides input and maintains the database (Ag balance) for timely execution of queries (monthly, quarterly & annual)
Per the FDA guidelines, provides PLRR updates to the assigned products
Provides input and follow-ups on DME alerts.
Maintains DME tracker
Medical review Team lead which includes HHE, DME Alerts, Clinical safety
Distribution of Aggregate reports and signal queries regularly.
Cortellis Intelligence Alerts maintenance
Degree in Medicine (MD) (preferred)
Knowledge of database management & use of coding dictionaries
Knowledge of ArisG, Ag signals, Ag balance and Inform database
High Level of computer literacy (Microsoft word, Excel, Powerpoint, Outlook and Adobe Acrobat
Clear, effective written & verbal communication skills